Spring in Washington, DC annually witnesses the ritual of Legislative Fly-Ins whereby many special interest groups descend on Capitol Hill to advocate their policy priorities. This year was no different, except for the fact that it was the first time such pilgrimages were made in three years due to the pandemic.
MichBio made two trips to Capitol Hill, one in early March focused on medical technology issues and under the auspices of AdvaMed, and another at the end of the month, aimed at covering biotech/pharma-related topics under the backing of BIO. In both instances, MichBio was joined by various representatives from Michigan’s biosciences industry – companies, NGOs and patient advocacy groups. A range of topics were covered – repeal of R&D amortization rules, IP protection and opposition to the TRIPS Waiver, VALID Act and a regulatory framework for all diagnostic tests, PBM transparency and full pricing benefits for patients, EPA limits to ethylene oxide levels and impacts for medical product sterilization, and many more.
Legislative Fly-In Participant Perspectives:
Gene Parunak of in2being, LLC
“This was my second time trying to keep up with MichBio’s Stephen Rapundalo as we literally and figuratively navigated the labyrinth that is Capitol Hill. It was an honor to be part of the MichBio delegation to the AdvaMed annual legislative fly in for medical devices on March 7th and 8th, 2023. As a lifelong techie and a politically agnostic person, I’ve rarely had interest in the “swamp” of DC, but on my first trip with MichBio in 2016, I learned that the conversations on the hill (away from the news cameras, which seem to act as divisive lenses) is actually thoughtful, nuanced, civil, and dare I say, human.
Joined by Desiree Mowry from Stryker, Stephen took us to visit every single Michigan congressional delegation (13 house, 2 senate). Cannon, Longworth, Rayburn, Hart… all the buildings and their myriad tunnels blend together as thousands of staffers, visitors, lobbyists and more race to their next meetings.
As in 2016, I was impressed by the engagement of the congressional staffers and their knowledge of the issues. They are also uniformly passionate about hearing from their constituents. The last time I was on the hill with MichBio, the issue of the day was the medical device excise tax, an ill-conceived effort that penalized pre-profit startup companies. Fortunately, that has since been repealed.
This trip, the issues were more numerous, including considerations of supply chain issues affecting all industries, but especially hurtful to the medtech industry which cannot quickly swap components without costly re-verification of devices. Also on the docket was encouraging CMS to provide gap coverage for FDA cleared breakthrough devices, since clearance is only part of the path to market. FDA staffing concerns are also creating review delays, and congress can take action to help FDA meet its commitments. Finally, the recent penalization of R&D by changes to the tax laws is making an unnecessary impact on startups. It does seem like lawmakers forget that pre-profit companies need all the help they can get, and accelerating tax write offs when no profit has yet been made is a low-burden way to boost startups.
It was a pleasure to be able to share on these topics from a personal perspective, and it made me once again realize that the impact of DC politics has a direct impact on us in Saline, MI – supply chain, review times, tax laws, reimbursement and a myriad other issues all affect what in2being and its clients experience.
I’m thankful to MichBio for pressing forward with what may seem like thankless and forgotten conversations in DC and in Lansing and allowing the rest of us to participate. They didn’t ask me to say that.
My only regret is that I didn’t practice harder to be able to keep up with Stephen’s brisk hiking pace”
Laura Bonnell of The Bonnell Foundation: Living with Cystic Fibrosis
“I was reminded of how important it is for legislators and aides to hear the patient’s voice. I encourage everyone to tell their story in Washington, D.C. They are listening. You can literally be at the table and be part of the change you hope to see.”